Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment
1 other identifier
interventional
200
1 country
1
Brief Summary
The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 14, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 18, 2016
August 1, 2016
3.9 years
February 14, 2015
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of HBeAg seroconversion
HBeAg seroconversion defined as HBeAg loss with anti-HBe antibody positive was evaluated during weeks treatment period
48 weeks
Secondary Outcomes (1)
rate of HBsAg loss
48 weeks
Study Arms (2)
entecavir with PEG-IFN a-2a
EXPERIMENTALafter enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks.
peginterferon alpha 2a
NO INTERVENTIONin this group, patients will be continue treated only with PEG-IFN a-2a for 48 weeks after enrolled.
Interventions
in this group, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 week.
Eligibility Criteria
You may qualify if:
- HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon a-2a treatment
You may not qualify if:
- Active consumption of alcohol and/or drugs
- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- History of autoimmune hepatitis
- Psychiatric disease
- Evidence of neoplastic diseases of the liver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Ditan hospital,Capital Medical University
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- liver disease center
Study Record Dates
First Submitted
February 14, 2015
First Posted
February 23, 2015
Study Start
January 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 18, 2016
Record last verified: 2016-08